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Subcutaneous Pharmacokinetics of Belatacept

NCT ID: NCT00569803

Last Updated: 2016-09-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-08-31

Brief Summary

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Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

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Detailed Description

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Conditions

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Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Belatacept 50 mg Subcutaneous Injection

Belatacept 50 mg subcutaneous (SC) injection

Group Type ACTIVE_COMPARATOR

belatacept

Intervention Type DRUG

single dose, 116 days

Belatacept 100 mg Subcutaneous Injection

Belatacept 100 mg SC injection

Group Type ACTIVE_COMPARATOR

belatacept

Intervention Type DRUG

single dose, 116 days

Belatacept 125 mg Subcutaneous Injection

Belatacept 125 mg SC injection

Group Type ACTIVE_COMPARATOR

belatacept

Intervention Type DRUG

single dose, 116 days

Belatacept 150 mg Subcutaneous Injections

2 SC injections of 75 mg Belatacept

Group Type ACTIVE_COMPARATOR

belatacept

Intervention Type DRUG

single dose, 116 days

Belatacept 200 mg Subcutaneous Injections

2 SC injections of 100 mg Belatacept

Group Type ACTIVE_COMPARATOR

belatacept

Intervention Type DRUG

single dose, 116 days

Belatacept 250 mg Subcutaneous Injections

2 SC injections of 125 mg Belatacept

Group Type ACTIVE_COMPARATOR

belatacept

Intervention Type DRUG

single dose, 116 days

Belatacept 125 mg Intravenous Infusion

125 mg Belatacept intravenous (IV) injection

Group Type ACTIVE_COMPARATOR

belatacept

Intervention Type DRUG

single dose, 116 days

Placebo

SC injection of placebo solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)

Interventions

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belatacept

single dose, 116 days

Intervention Type DRUG

Placebo

Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women ages 18 to 65 years old
* Subjects must weigh less than or equal to 100 kg

Exclusion Criteria

* Inability to tolerate injections or IV infusions
* autoimmune disorders
* TB
* herpes
* HCV
* HBV
* HIV
* bacterial or viral infection
* history of cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Ppd Development

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IM103-046

Identifier Type: -

Identifier Source: org_study_id

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